GMP Compliance Certification
GMP Compliance CertificationOur laboratories are certified in compliance with Good Manufacturing Practice (GMP) by the Spanish Agency for Medicines and Health Products (AEMPS) and the General Directorate of Health Order and Regulation (Government of Catalonia).
Manufacturing and Importation Authorisation
Our laboratories are authorized as manufacturer and import laboratories by the Spanish Agency for Medicines and Health Products (AEMPS), which allows us to import, control and release medicines within the European Union.
FDA Approval
Our Madrid and Girona laboratories are approved by the FDA (U.S. Food & Drug Administration) as testing laboratories for active ingredients, finished products, as well as for in vitro bioequivalence studies and bioanalysis.
Drug Establishments Current Registration Site
Generic Drug Facilities, Sites and Organization Lists
ISO/IEC 17025 Accreditation for Microbiological Testing
Our Madrid laboratory is accredited by ENAC (Spanish National Accreditation Body) in accordance with the UNE-EN ISO/IEC 17025 standard as a microbiology laboratory for primary packaging materials used in healthcare products (Accreditation No. 1468/LE2704).